Nefopam for Post Video-Assisted Thoracoscopic Lobectomy | NCT04241640

Studies
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

NCT04241640

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Nov 20, 2024Actual

Enrollment

72Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Nefopam 20 MG/ML
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 24, 2020

First Posted Date

Jan 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nefopam group[	Experimental		Drug: Nefopam 20 MG/ML
placebo group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nefopam 20 MG/ML	Drug	Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative	Nefopam group[

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morphine consumption in first 24 hours post-operative	morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative	24 hours

Secondary Outcomes

Measure	Description	Time Frame
numeric pain score	numeric pain score in 1, 2, 12, 24 hours after surgery	24 hours
side effect of nefopam	side effect of nefopam: tachycardia, sweating, nausea, vomiting, sedation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
Can operate a patient-controlled analgesia (PCA) device
No contraindication for nefopam

Exclusion Criteria:

Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
Creatinine clearance < 60 ml/min
Liver disease: child-pugh score B or C
Allergy to nefopam
Chronic opioid use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of medicine Siriraj hospital		Bangkok		10600	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009340	Nefopam

Ancestor Terms

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided